By applying short electric pulses to cells, the cell membranes can become permeabilised (electroporation). This can be used augment the effect of chemotherapy, by providing direct access to the cell cytosol. For the drug bleomycin, the enhancement of effect is several hundred fold, enabling once-only treatment. The investigators wish compare electrochemotherapy with radiotherapy when treating ulcerated cutaneous metastases up to 5 cm in diameter from any kind of histology.

Intratumoral or intravenous bleomycin followed by electric pulses. Once only treatment.

Other Name: ECT

Drug: Bleomycin

Intratumoral or intravenous bleomycin followed by electric pulses. Once only treatment.

Active Comparator: radiotherapy

Radiation: Radiotherapy

Radiotherapy according to hospital procedures.

Other Name: RT

Detailed Description:

About 5 % of all cancer patients experience cutaneous metastases. Ulcerating metastases can be of great psychological distress for the patients and may also be painful. Radiation therapy is standard treatment for ulcerating metastases, but there are no reports of response rate.

With this study we wish to compare electrochemotherapy with radiotherapy when treating ulcerated cutaneous metastases up to 5 cm in diameter from any kind of histology.

Patient recruitment: 98 patients are to be recruited, the patients will be randomized between electrochemothreapy or radiotherapy. 49 patients will be treated in each arm.

Treatment: Patients will be treated in local or general anesthesia (inhaling max. 30 % oxygen) Bleomycin will be given either intratumoral or intravenous. Electric pulses will be administered using a square wave electroporator (IGEA, Carpi, Italy). Needle and plate electrodes are used in order to treat the affected area efficiently. Eight pulses at a frequency of 5000 Hz or 1 Hz will be used for each application of the electrodes. In this way, a large area can be treated within a short time. Post treatment, the area will be covered by dry dressings, as are standardly used.

The patients will be seen at 8, 30, 60, 90 and 180 days post treatment. Chest X ray will be taken before and after treatment for the patients receiving electrochemotherapy.

Evaluation: Evaluation is performed by measurement of lesion extension and digital photography using the RECIST criteria. The first 10 patients in each treatment arm will also be PET/CT-scanned before and one week after treatment.

Safety: Safety will be reported both in terms of evaluation of adverse events and in terms of patient satisfaction determined by questionnaire, including the 'Derriford Appearance Questionaire'.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Age ≥ 18.

Histological proven cancer, any histology.

Progressive and/or metastatic disease.

One or more ulcerating cutaneous metastases.

Patient in need of palliation of the ulcerating metastases.

Lesion to be treated between 1 cm - 5 cm in diameter.

Lesions to be treated must be either stationary or progressing during any concomitant chemotherapy.

Abnormal DLCO. If clinical history of or suspected reduced lung capacity, DLCO must be performed.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00918593